FORWARD-LOOKING STATEMENTS AND MARKET DATA
This prospectus and the documents incorporated herein by reference contain forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management, and we anticipate that the applicable prospectus supplement will contain such forward-looking statements as well. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “might,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “aim,” “potential,” “continue,” “ongoing,” “goal,” “forecast,” “guidance,” “outlook,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.
These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this prospectus and the documents incorporated herein by reference include, but are not limited to, statements about:
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the success, cost, enrollment, and timing of our clinical trials;
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the success, cost and timing of our product development activities;
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the ability of us or our third-party contract manufacturers to continue to manufacture tumor infiltrating lymphocytes, or TIL, in accordance with our selected process;
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our ability to design, construct and staff our own manufacturing facility on a timely basis and within the estimated expenses;
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the success of competing therapies that are or may become available;
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regulatory developments in the United States of America, or U.S., and foreign countries;
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the timing of and our ability to obtain and maintain U.S. Food and Drug Administration, or the FDA, or other regulatory authority approval of, or other action with respect to, our product candidates;
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our ability to attract and retain key scientific or management personnel;
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the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
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our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates;
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the ability and willingness of our third-party research institution collaborators to continue research and development activities relating to our product candidates;
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the potential of our other research and development and strategic collaborations;
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our expectations regarding our ability to obtain and maintain intellectual property protection for our manufacturing methods and product candidates;
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our plans to research, develop and commercialize our product candidates;
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the size and growth potential of the markets for our product candidates, and our ability to serve those markets;
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our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
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fluctuations in the trading price of our common stock; and
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our use of cash and other resources.
Actual results may differ from those set forth in this prospectus and the documents incorporated herein by reference due to the risks and uncertainties inherent in our business, including, without limitation: the